DETAILED ACTION
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9,326,707. Although the claims at issue are not identical, they are not patentably distinct from each other because it is largely a broader recitation of the claims found in the above patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,730,650. Although the claims at issue are not identical, they are not patentably distinct from each other because it is largely a broader recitation of the claims found in the above patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,272,890 in view of claims 1-11 of U.S. Patent No. 9,326,707. Claim 1 of the ‘246 patent recites the limitations of claim 1 with the exception of determining a rate of occurrence of the glycemic excursion events over a predetermined time period or determining the alarm parameter on the basis of said rate. Claims 1, 6, and 8 of the ‘707 supplies this. It would have been obvious to modify the ‘848 patent with that of the ‘707 patent to yield the predictable result of alarm settings matched to the individual patient’s glycemic and alarm history.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,678,848 in view of claims 1-11 of U.S. Patent No. 9,326,707. Claims 1 and 6 of the ‘848 patent recite the limitations of claim 1 with the exception of determining a rate of occurrence of the glycemic excursion events over a predetermined time period. Claim 1 of the ‘707 supplies this. It would have been obvious to modify the ‘848 patent with that of the ‘707 patent to yield the predictable result of alarm settings matched to the individual patient’s glycemic and alarm history.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,357,246 in view of claims 1-11 of U.S. Patent No. 9,326,707. Claim 1 of the ‘246 patent recites the limitations of claim 1 with the exception of determining a rate of occurrence of the glycemic excursion events over a predetermined time period or determining a frequency of alarm activations as analytical inputs to the setting step. Claims 1, 6, and 8 of the ‘707 supplies this. It would have been obvious to modify the ‘848 patent with that of the ‘707 patent to yield the predictable result of alarm settings matched to the individual patient’s glycemic and alarm history.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siddiqui et al. (US 2005/0027182) in view of Hanood (US 2004/0140892).
As to claim 1, Siddiqui teaches a method performed by a receiver of an analyte monitoring system as well as the corresponding receiver, the method comprising: receiving analyte data detected by an analyte sensor ([0053], [0056]); monitoring the analyte data over a predetermined time period ([0140]; Fig. 6C); identifying a plurality of glycemic excursion events occurring during the predetermined time period ([0024] – the number of excursions above and below threshold values); determining a rate of occurrence of the glycemic excursion events ([0024] – rate simply being the number of occurrences over the monitored time period; [0140] – distribution can be shown in percentages scaled with duration of monitor use); and records the number of alarm activations and an analyte level associated with the alarm activations ([0112], [0123-0124]), and setting the alarm parameter associated with a selected alarm type and using the set alarm parameter to determine whether to activate an alarm of the selected alarm type in response to subsequently received analyte data ([0111], [0115-0118]). Siddiqui also teaches the receiver device itself (104), comprising processors (108) and memory (110) storing instructions ([0054]).
However, Siddiqui fails to expressly teach determining a frequency of alarm activations associated with the glycemic excursion events and determining an alarm parameter based on one or more of: (i) the determined rate of occurrence of the glycemic excursion events, (ii) the determined frequency of alarm activations associated with the glycemic excursion events, or (iii) an analyte level associated with the alarm activations.
Hanood teaches determining a frequency of alarm activations and determining an alarm parameter based on the determined frequency of alarm activations ([0010], [0013] – determines the frequency of a sensed event, and in the case of frequent repetition, will trigger the alarm threshold adjuster to adjust the sensitivity threshold for which an alarm will sound). It would have been obvious to modify Siddiqui with Hanood to utilize the frequency of glycemic alarm activations already stored in its alarm history to reduce nuisance alarms, as Siddiqui already notes that duplicative warnings can be a nuisance to the user ([0131]) and that simply reducing/raising the threshold could be unsafe ([0007]). Hanood similarly warns notes the identical failure in its own field, in that “frequent false alarms may be ignored” ([0007]).
As to claims 2 and 12, Siddiqui teaches the glycemic excursion events comprise one or more of hypoglycemic events, hyperglycemic events, impending hypoglycemic events, or impending hyperglycemic events ([0071], [0139]).
As to claim 3, Siddiqui teaches determining: (i) the determined rate of occurrence of the glycemic excursion events ([0024]), (ii) the alarm activations associated with the glycemic excursion events ([0123]), and (iii) the analyte level associated with the alarm activations ([0123]). Siddiqui fails to expressly teach determining the alarm parameter based on each of these three quantities. Hanood teaches determining the alarm threshold from more than one determined attribute of the recorded alarm activations, namely both their frequency and their magnitude ([0027], [0030]). It would have been obvious to modify the combination further with Hanood so that the alarm parameter is determined from all three determined parameters, as it would yield a better result for personalizing the alarm to the individual.
As to claims 4 and 13, Siddiqui teaches the analyte level associated with the alarm activations is determined based on analyte data received from a transcutaneously positioned analyte sensor ([0048], [0050]).
As to claims 5 and 14, Siddiqui teaches determining a rate of change of analyte levels associated with the glycemic excursion events, wherein determining the alarm parameter is further based on the determined rate of change ([0076] – calculation of a slope, [0079] – criteria can be parameterized to allow customization).
As to claims 6 and 15, Siddiqui teaches programming an alarm function associated with the selected alarm type ([0115-116], Fig. 4D).
As to claims 7 and 16, Siddiqui teaches programming a notification function associated with the selected alarm type ([0126]).
As to claims 8 and 17, Siddiqui teaches that the alarm triggering threshold is a modifiable parameter ([0111], [0137] – limits can be adjustable thresholds) but fails to expressly teach modifying an alarm triggering threshold based on the determined frequency of alarm activations.
Hanhood teaches modifying an alarm triggering threshold based on the determined frequency of alarm activations ([0027], [0030-31]). It would have been obvious to further modify the above combination with Hanhood to reduce duplicative warnings, as noted in claim 1 above.
As to claims 9 and 18, Siddiqui teaches monitoring analyte levels during the predetermined time period; detecting occurrences of the analyte levels crossing a predetermined threshold; and determining the rate of occurrence based on the detected occurrences within the predetermined time period ([0137], [0139], [0140], [0149]).
As to claims 10 and 19, Siddiqui teaches the selected alarm type comprises an alarm associated with a hypoglycemic event, a hyperglycemic event, an impending hypoglycemic event, or an impending hyperglycemic event ([0060], [0071], [0111]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 9/16/26
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